CTS gives medical device manufacturers an FDA-compliant leak/blockage test

Market Requirements:

FDA's 21 CFR Part 11 compliancy matters for many medical device manufacturers. Cincinnati Test Systems (CTS) has worked extensively with our customers in the medical device industry to identify what capabilities a leak/blockage test system must have to be compliant.

The results have been distilled into our Sentinel Blackbelt Pro. It delivers the features and functionality medical device manufacturers need to ensure their leak test is compliant with 21 CFR Part 11 and EU Annex 11.